CN104039245A - Expandable occlusion device and methods - Google Patents
Expandable occlusion device and methods Download PDFInfo
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- CN104039245A CN104039245A CN201280048878.1A CN201280048878A CN104039245A CN 104039245 A CN104039245 A CN 104039245A CN 201280048878 A CN201280048878 A CN 201280048878A CN 104039245 A CN104039245 A CN 104039245A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00592—Elastic or resilient implements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00619—Locking means for locking the implement in expanded state
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00623—Introducing or retrieving devices therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00632—Occluding a cavity, i.e. closing a blind opening
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00853—Material properties low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
- A61B2017/00871—Material properties shape memory effect polymeric
Abstract
An occlusion device and method for occluding an undesirable passage through tissue, such as a septal defect, that provides an expandable cylinder or other structure that occludes the passage internally or by covering one or more openings to the passage. The occlusion device includes a wire lattice or mesh that expands from a contracted catheter-deliverable state to an expanded state that occludes the passage. The lattice or mesh has one or more layers, with layers that provide structural support to the device, and layers that provide a lattice braiding or pore sizes that promote further occlusion by a biological process, such as tissue ingrowth that further occludes the affected passage.
Description
The cross reference of related application
The application requires the priority of the U.S. Provisional Patent Application 61/525,680 of submitting on August 19th, 2011 and the U.S. Provisional Patent Application 61/636,392 of submitting on April 20th, 2012, by quoting, is incorporated to the whole of them.
Technical field
This technology briefly relates to cardiovascular devices, implant delivery system, and the method for the treatment of the structural and functional defect in heart and blood circulation with cardiovascular devices and delivery system.More specifically, the flow characteristic of the obturation that this technology relates to less desirable channel of blood flow to repair or to alleviate structural heart defect and/or weaken.
Background technology
Human heart and blood circulation may have the less desirable channel of blood flow that needs treatment, for example, hinder the structural heart defect of the proper flow of blood.This passage may be the result of ectrogeny or disease or wound.As example, healthy human heart is divided into the chamber of four main containment bloods, is called left atrium and left and right ventricles.Muscular wall or interval separate the right heart that comprises right atrium and right ventricle with the left heart that comprises left atrium and left ventricle.Right heart blood supply to lung (pulmonary) circulates with oxygenation, and left mind-set health provides subsequently the circulation of oxygenation.In heart of fetus before birth, the blood of oxygenation is provided by mother, and therefore, little opening is present in heart of fetus and main vascular to avoid pulmonary circulation.Conventionally, these openings at once merge or are functionally closed after birth when baby starts to breathe.Yet, in congenital heart defect, these openings or in some cases other similar deformities can not be suitably closed, cause potentially various hearts and relevant problem thereof, comprising: congestive heart failure, pulmonary hypertension, hidden originality apoplexy, transient ischemic attack (TIA), grumeleuse, thromboembolism, migraine etc.Common structural heart defect comprises: atrial septal defect (ASD) (as shown in fig. 1), patent foramen ovale (PFO), ventricular septal defect (VSD) (shown in Fig. 2), and patent ductus arteriosus (PDA).Fig. 1 shows: heart 900, right atrium 901, right ventricle 902, left atrium 903, left ventricle 904, atrial septal defect 905, from the blood flow 906 of health, towards the blood flow 907 of lung, and from the blood flow 908 of lung.Fig. 2 shows: heart 910, right atrium 911, right ventricle 912, left atrium 913, left ventricle 914, ventricular septal defect 915, from the blood flow 916 of health, towards the blood flow 917 of lung, and from the blood flow 918 of lung.
In ASD, blood can flow to right atrium through interatrial septum from left atrium, causes the mixing of arterial blood and venous blood (shunting) and the right atrial pressure increasing, and the two can be important clinically.In PFO (shown in Fig. 3), the tissue flap of crossing over left interatrial septum opening (oval foramen) does not merge and closes.Because the pressure in left atrium is usually above right atrium, in the estimation 25 to 30% of adult colony of suffering from this disease, this lobe keeps functional closing conventionally.Yet, evidence suggests, in some of these patients, (for example, during coughing) this lobe is opened along with follow-up shunting sometimes, can cause the event of some above-mentioned bad neurological and vascular.Fig. 3 shows: heart 920, right atrium 921, right ventricle 922, left atrium 923, left ventricle 924, patent foramen ovale 925, superior vena cava 926, and postcava 927.
VSD is the common type of congenital heart defect generally, and its split shed is present in the interventricular septum between the right heart and the left heart.This type of is damaged not general before birth, but estimates to be present in 0.2 to 0.4% neonate.Although in ASD, this opening some time after birth may close, persistence opening can allow arterial blood from left ventricle to the less desirable shunting of right ventricle.
The short blood vessel that is called ductus arteriosus, avoids resisting the means of high-drag pumping of the lung of unaerated as the right ventricle of protection fetus, play the effect from pulmonary artery to aorta shunting blood.This blood vessel is conventionally closed immediately after birth.The closure of this blood vessel is unsuccessfully called as PDA, and can finally cause congestive heart failure.
In view of the relevant important health result of the existence to less desirable channel of blood flow in heart or blood circulation, need for inaccessible device and the technology of passage like this.It is believed that existing device and technology with the inaccessible less desirable channel of blood flow of implantable device suffer some defects, comprising:
1) flexibility that can not subside and keep being enough to sending by the device of blood vessel reliably by means of minor diameter guide,
2) during dermal delivery, be not enough to the location and the bearing that provide accurate and controlled,
3) to such as defect size, shape, tissue thickness and with the design of the anatomy challenges such as variation of the adjacency of important structure such as coronary sinus consider insufficient,
It is 4) not enough to damaged sealing,
5) device is insufficient fixing,
6) unsuitable hematodinamics design and/or material select to cause too much thrombosis or thrombosis-thromboembolism,
7) the structural fatigue rupture of assembly,
8) after implantation, be not enough to the tissue ingrowth and the healing that provide natural,
9) due to scratch and/or the erosion of the tissue of the contact device due to unsuitable size Selection, porosity and/or rigidity characteristic,
10) unsuitable size Selection hinders cardiovascular function, for example in the treatment of PFO to aortal impact, and
11) in for example formation of thrombosis on hub of surperficial outthrust.
Therefore, need to solve the one or more apparatus and method in these defects.
Accompanying drawing explanation
Accompanying drawing, is merged in herein and forms the part of this description, and the embodiment of this technology is described, and together with the general description providing above and the following detailed description providing in order to the feature of this technology to be described.
Fig. 1 is the viewgraph of cross-section of suffering from the human heart of atrial septal defect.
Fig. 2 is the viewgraph of cross-section of suffering from the human heart of ventricular septal defect.
Fig. 3 is the viewgraph of cross-section of suffering from the human heart of patent foramen ovale.
Fig. 4 is the side view at an embodiment of the locking device as described in this technology of heart defect place implantation.
Fig. 5-9th, the side view of an embodiment of the locking device of Fig. 4 and the delivery apparatus as described in this technology.
Figure 10 is for the manufacture of the axle of screen work and the side view of fabric as described in this technology embodiment.
Figure 11 A is the schematic diagram of the screen work assembly of the locking device as described in this technology embodiment.
Figure 11 B is the isometric projection image of the screen work assembly of Figure 11 A.
Figure 11 C is the schematic diagram of locking device that comprises the screen work assembly of Figure 11 A.
Figure 12 is the viewgraph of cross-section of the embodiment of Figure 11 A.
Figure 13 and 14 is the side view of the alternate embodiments of the locking device as described in this technology.
Figure 15 A is the viewgraph of cross-section of other embodiment of the locking device as described in this technology.
Figure 15 B is the schematic diagram of embodiment of layering of the embodiment of Figure 15 A.
Figure 16 is the viewgraph of cross-section of other embodiment of the locking device as described in this technology.
Figure 17 A-17D is the partial cross-sectional view of the alternate embodiments of the locking device as described in this technology.
Figure 18 is the viewgraph of cross-section of embodiment of locking device as described in this technology and an embodiment of delivery apparatus.
Figure 19 is the expanded view of the locking device of Figure 18 and a part for delivery apparatus.
Figure 20 is the viewgraph of cross-section of an alternate embodiments of the locking device as described in this technology.
The specific embodiment
Described locking device and some embodiments of delivery system are implanted in self-expansion type blocking element in tissue and have less desirable passage part herein, for example, extend into the channel of blood flow in heart tissue or vascular tissue." passage " is included in tissue or through the enterable opening of organizing while using in this article, for example, the two-part two ends passage (for example, passing the passage at interval) that connects cardiovascular system, (for example terminate in in-house blind pipe or single-ended passage, left auricle or aneurysm), leave the passage (for example, bleeding part) of cardiovascular system, and/or anatomic passageway (for example, blood vessel, or, the pipeline of organ or conduit).As described below, blocking element can be inaccessible or inaccessible less desirable passage at least in part, and the structure of blocking element and shape can have the multilamellar of at least one inaccessible self-expansion type screen work of controlling this passage.Blocking element itself can be primitively inaccessible this passage of part, then the rapid induction biological respinse of this screen work that entirely shuts.
1.
the enforcement of locking device
Fig. 4 is the side view being implanted in through an embodiment of the locking device 10 with the first blocking element 16 and the second blocking element 18 at passage 12 places at the interval 14 of heart.Blocking element 16,18 can comprise frame structure 19 separately separately.In several embodiments, frame structure 19 can have at least one material net, and for example silk material fabric has dish type after implantation.The first blocking element 16 also can comprise respectively outer hub and interior hub 26 and 28 that are connected with the end of the frame structure 19 of the first blocking element 16, similarly, the second blocking element 18 can have outer hub and interior hub 32 and 30 that are connected with the end of the frame structure 19 of the second blocking element 18.Each hub 26,28 and 30 can have pipeline 33.Locking device 10 also can comprise tethers (tether) 34, and it is through the pipeline 33 of hub 26,28 and 30, and the far-end of tethers 34 can be connected to the outer hub 32 of the second blocking element 18.In this concrete embodiment, the frame structure 19 of the first blocking element 16 is separated with the frame structure of the second blocking element 18 19.
After implantation, a side of outer peripheral portion 20 contact intervals 14 of the first blocking element 16 is with an opening 12a of overlay path 12, and the opposite side of the outer peripheral portion contact interval 14 of the second blocking element 18 is with the relative opening 12b of overlay path 12.For example, can tractive tethers 34, thus it slides through hub 26 and 28 to pull the first and second locking device 16,18 opposite sides near interval 14.This is squeezed on interval frame structure 19 and end 12a and the 12b of overlay path 12.
In an embodiment of Fig. 4, only referring to the first blocking element 16, frame structure 19 can comprise at least one deck screen work layer 36, and its extension spreads all over the whole surface of the first blocking element 16 with inaccessible path 12.The silk material of frame structure 19 or the crossing member of other type can be set to provide the opening of hole 38 or other type, and the opening of this hole 38 or other type promotes further inaccessible by the biological process on frame structure 19.Shown screen work layer 36 also defines the internal volume 40 of the first blocking element 16, and tethers 34 is through it.Can understand, the second blocking element 18 shown in Fig. 4 can have the structure identical with the first blocking element 16.
2.
delivery system and method
In Fig. 5-9, show for implanting the delivery system of locking device 10 and the embodiment of method.For clear, Fig. 5-9 show the partial cross-sectional view of interval tissue 14 and the side view of the first and second blocking elements 16,18.
Referring to Fig. 5, an embodiment of delivery system 100 comprises conduit 102, and it has the sheath 108 that is inserted into implantation site 104 on the seal wire 106 of pre-placement in order to cover is set.Seal wire 106 can have for accepting the chamber of tethers 34 (Fig. 4), and the arrangement of seal wire 106 and the follow-up insertion that covers the conduit 102 on seal wire 106 can utilize known imaging system and technology to carry out.In one embodiment, utilize outside imaging means, such as fluoroscopy, X-ray, MRI etc., inserts and is advanced into heart by seal wire through femoral vein or radial artery, thereby the far-end of seal wire is guided to and wants inaccessible path.As shown in Figure 5, settle seal wire 106, thereby it extends through path 12.Radiopaque labelling (not shown) can be mixed in seal wire, conduit or locking device itself, thereby provide extra visibility under video picture guiding.Marker material can comprise: tungsten, tantalum, platinum, palladium, gold, iridium, or other applicable material.In this stage of the method, the first and second blocking elements 16 and 18 (not shown in Fig. 5) can be limited in sheath 108 with low profile (low-profile) or the state shrinking, and conduit 102 is pushed on seal wire 106 simultaneously.
Referring to Fig. 6, at the far-end 102a of conduit 102, through behind interval 14, sheath 108 is drawn back and/or the second blocking element 18 is advanced, thereby the second blocking element 18 is placed in to the distal side at interval 14.For example, at sheath 108, when proximal direction is retracted, the second capped blocking element 18 is not enough to allow frame structure 19 self-expandings.
Referring to Fig. 7, when sheath 108 is pulled, tethers 34 can keep being connected with hub 32, thereby contributes to make the second blocking element 18 to remain on appropriate location.Or tethers 34 can be inserted into and be fixed to the second blocking element 18 when seal wire 106 is removed.At the second blocking element 18, remove sheath 108 completely and be expanded to after the size that is greater than path 12, seal wire 106 is removed so that tethers 34 is retained in appropriate location, as shown in Figure 7 from this space then.Can apply tension force to tethers 34 and settle far-end blocking element 18 with the tissue 14 against around path 12.Or, tethers itself can utilize the contractility being produced by the design of this tethers or material character to carry out or contribute to the arrangement of far-end blocking element 18, for example, setting in order to the tethers of being made by tensile elasticity material towards the relative hub of tractive each other, there is the tethers of expansion tension spring structure, and/or there is the tethers of shape memory character.
Fig. 8 be presented at sheath 108 at proximal direction by the stage of the method after further being drawn back to manifest the first blocking element 16 and hub 26,28.After expansion, the first blocking element 16 is distally advanced the interval 14 with against around path 12 to settle the first blocking element 16.
Fig. 9 is presented at the first blocking element 16 and by far-end, is moved more close the second blocking element 18 effectively to shorten the stage that extends in the method after the length of tethers 34 parts between the interior hub 28 of the first blocking element 16 and the interior hub 30 of the second blocking element 18 subsequently.Thereby the first blocking element 16 is advanced while tension force to remain on tethers 34 by far-end the first and second blocking elements 16,18 are tied, thus the interval 14 around path 12 applied to compression stress and form the obturation substantially to path 12.Then that the position of hub 26,28,30 and 32 is fixing to maintain the layout shown in Fig. 9 with respect to tethers 34.Locking member (retaning element, not shown) can be used to make the first and second blocking elements 16,18 to nestle up interval 14.For example, locking member can be the assembly of the first blocking element 16 or the assembly separating.
3.
frame structure and formation
In any embodiment as herein described, the screen work that this blocking element can have a material, filament, line, stitching thread, a fiber etc. (for example, net), it has been configured to form fabric or the structure (for example, the fabric of porous or structure) with opening.This screen work can be used metal, polymer, composite and/or biomaterial to construct.Polymeric material also can comprise polymer, for example, and Dacron, polyester, polypropylene, nylon, Teflon, PTFE, ePTFE, TFE, PET, TPE, PGA, PGLA or PLA.Can use other applicable material known in flexible implant field.Metal material can include but not limited to Ni-Ti alloy (for example Nitinol), platinum, cobalt-chromium alloy, Elgiloy, rustless steel, tungsten or titanium.In some embodiments, be applicable to, this screen work is only constructed by metal material and is not mixed any polymeric material, not containing polymer.In these and other embodiment, be applicable to, the integral body of locking device is to be made by the metal material that does not contain any polymeric material.It is believed that getting rid of in some embodiments polymeric material can be reduced in thrombotic probability on apparatus surface, and think and get rid of polymer and only use metal component that the locking device having compared with thin contour can be provided, compare with the device that contains polymers compositions, can use less catheter delivery.
This screen work can be the mesh grid of a material.This mesh grid can cover in axle and form, as known in tubular braid production field.Then, can utilize heat setting method further to make tubular braid be shaped.This fabric can be for example tubular braid of Nitinol, platinum, cobalt-chromium alloy, rustless steel, tungsten or titanium of filament material.This screen work can be at least in part formed by the cylindrical fabric of elastic filament.This fabric can radially be tied and self-expanding when removing radial constraint in the situation that of plastic-less deformation.In several embodiments, the thickness of fabric filament can be less than about 0.2mm.For example, this fabric can be manufactured to the silk material within the scope of about 0.15mm at about 0.015mm by diameter.
Figure 10 shows according to the mesh grid forming in axle known in tubular braid manufacture field.Braid angle (α) can be controlled by various means of different known in filament braiding field.Fabric for this screen component can have constant substantially braid angle in the length of assembly, or can change to provide the not same district with hole dimension and radial rigidity.Then, utilize heat setting method further to the mesh grid of tubulose, to formalize.Referring to Figure 10, as known in thermal finalization field, braiding filament 201 for example Nitinol silk, holder, axle or mould 200 can be used to make the tubular structure 202 of braiding to keep the structure of its expectation to accept suitable heat treatment simultaneously, thereby the elastic filament of the tube element of this braiding presents or be shaped as the outline of axle or mould 200.The wire-element of net device or assembly can be set up with so that this device or assembly keep the holder 203 of shape of expectation fixing, in the situation of Nitinol silk, be heated to about 475-525 ℃ about 5-30 minute so that this structure setting.Other heating means are feasible and depend on the character that weaves selected material.For example, this fabric can be for example tubular braid of Nitinol, platinum, cobalt-chromium alloy, 35N L T, Elgiloy, rustless steel, tungsten or titanium of a material.In some embodiments, this device can be at least in part formed by the cylindric fabric of elastic filament.Therefore, this fabric can radially be tied and can self-expanding when removing radial constraint in the situation that of plastic-less deformation.The thickness of fabric filament or diameter can be less than about 0.5mm.This fabric can be manufactured to a silk material of about 0.40mm at about 0.02mm by diameter or average diameter.Device or assembly can have high braiding angular region, and wherein this braid angle is greater than approximately 60 degree.Such fabric with shape memory and/or elastic filament is called as " self-expanding " in this article.
For part, assembly or the element of braiding, braiding process can be woven and be carried out by automatic machinery, or can also be undertaken by craft.For some embodiments, this braiding process can by by people such as Marchand, submitted on October 17th, 2011 be entitled as " knit unit and using method " the 13/275th, knit unit described in No. 264 U.S. Patent applications and method are carried out, and by the full text of quoting it, are incorporated herein.In some embodiments, can use knit unit, comprise: define the pan of plane and periphery, from the center of this pan, extend and substantially perpendicular to the axle of the plane of this pan, and a plurality of actuators of settling of the edge along periphery around this pan.Many filaments are loaded in axle, so every filament extends towards the peripheral radial of this pan, and every filament meshing point place on this periphery contacts this pan, with the discrete distance in adjacent meshing point interval.Every filament meshes the point at periphery place of this pan and the some separation distance " d " at the periphery place that every next-door neighbour's filament meshes this pan.This pan and a plurality of fixture are set up relative to each other and move, thus the filament that makes the first subgroup with respect to the filament rotation of the second subgroup with weaving filament.Many filament driven member engagements of the first subgroup, and a plurality of actuator turns round and make engaged filament in cardinal principle direction radially, move to the position of the periphery that exceeds pan.Then, make this pan with all linear distance rotation first directions, make thus the filament rotation discrete distance of the second subgroup and the filament of this first subgroup is intersected on the filament of the second subgroup.Actuator is turned round again so that the filament of this first subgroup moves to the radial position on the periphery of this pan, thereby the released all linear distances lighting from its last engagement of every filament wherein in this first subgroup mesh the periphery of this pan.
Figure 11 A and 11B show an embodiment as the screen work of the assembly of locking device or braiding 205.As shown in signal in Figure 11 A, screen work 205 has two-layer, skin 207 and internal layer 209.Outer 207 have the columniform part 211 of screen work 205, the part 213 of taper, planar shaped part 215, and assemble end 217, and internal layer 209 has the wavy part 219 of screen work 205, the part 221 of taper, planar shaped part 223, and assemble end 225.At edge, 227 places contact outside tapering part 213 with interior tapered part 221, at this place's screen work 205, are turned up (self inverse folding) and define the inner volume 231 of the 229 generation screen works 205 that portal.In the embodiment shown, screen work 205 has the tubular braid of " 360Nitinol " silk material of 0.025mm (0.001 inch) diameter.In the manufacture of screen work 205, as described herein tubular braid is carried out to thermal finalization along the wavelike segments 219 formation undulation things 233 of internal layer 209.
In the schematic diagram of Figure 11, for clear, shown the interval 235 between skin 207 and internal layer 209.Can understand, outer 207 can contact each other substantially with internal layer 209, therefore in some positions, there is no interval, and the contact between skin 207 and internal layer 209 can allow the distortion when they rely on each other of these layers, as shown in Figure 11 B, outer 207 part presents depression 239, and outer 207 part extends between adjacent undulation thing 233.It can also be appreciated that undulation thing 233 provides substantially closed ring body to amass 237, extends along periphery between skin 207 and internal layer 209.
Referring to Figure 11 A, skin 207 and internal layer 209 are parts of identical fabric or screen work 205.As mentioned above, the valgus timesharing that the braiding feature of screen work 205 can be centered around 227 places, edge continuously at this fabric keeps constant, or can form by two or more knitting skills, so the braiding of (internal layer 209) is different from the braiding of on skin (outer 207) on inner side, thereby realize the feature of expectation.For example, can change braiding so that different braid angle or hole dimensions to be provided.
Figure 11 C schematically shows that the outside screen work 205 that conduct and inner screen work 252, first hub 254 with outer groove 258 and the second hub 256 are assembled is arranged on screen work 205 assemblies in locking device 250.Outside screen work 205 has the end 217 and 225 that is fixed to hub 256, and is placed in the outer groove 258 of the first hub 254 in the part of turning up of edge 227 place's screen works 205.End 217 and 225 can be fixed to hub 256 by welding, and edge 227 is fixed to hub 254 by groove 258 and the size that makes this edge 227 remain on the hole 229 in groove 258.The groove 258 that locking element (not shown) can be fixed to hub 254 is to guarantee and the engaging of edge 227.Inner screen work 252 has and is fixed to the first end 260 of the first hub 254 and the second end 262 that is fixed to the second hub 256 by for example welding.In the embodiment of Figure 11 C, outside screen work 205 is to provide the outer inaccessible screen work of obstruction layer, and inner screen work 252 is to arrange in order to support the structural screen work of inaccessible screen work.In one embodiment, (for example there is crin material, the screen work of fabric about 0.050mm to 0.50mm) can (for example be used as structural screen work in locking device, inner screen work 252), its outside screen work (for example outside screen work 205) can with the obstruction layer of being furnished with thin screen work or basketwork structure covers.By structural support being placed in one or more layers obstruction layer, this inner structure supporting layer can be provided for promoting locking device and around most of radial force of organizing for example sealing between blood vessel, left auricle or spaced walls of wanting inaccessible path.
Thereby can tectonic framework layer or the part of screen work layer there is the aperture as the height occlusive element of locking device.One deck can have at least a portion of this layer, and this part has the average effective hole dimension between about 0.050mm and about 0.300mm.Can use the obstruction layer with the effective hole dimension of maximum between about 0.050mm and about 0.250mm.Can techonosphere or the part of layer so that macropore main as support structure with provide radial force to promote other layer to the complying with of structures surrounding to be provided, this device is provided thus and organize between sealing.The radial force being provided by structural component or layer also can suppress movement, displacement and the potential thromboembolism of this device.Structural component or layer can have approximately 0.20 and 1.50mm between the effective hole of maximum.Locking device can have one or more layers structural screen work layer and maximum effectively one or more layers less inaccessible screen work layer of hole dimension of maximum effectively hole dimension large (for example, being greater than about 0.250mm).The ratio of the effective hole dimension of maximum of structural screen work layer and inaccessible screen work layer can be between approximately 1.5 and 6.The difference of the effective hole dimension of maximum of structural screen work layer and the effective hole dimension of maximum of inaccessible screen work layer can approximately 0.100 and 0.800mm between.Being greater than approximately 5 holes and this number averaged and determined around the periphery that maximum effectively hole can be tended in the hole of locking device reach maximum by measurement.
The shape of screen work synergism together with porous provides the support of damaged obturation and biological adaptation to promote that new organization is inwardly grown, newly-endothelialization (neo-endothelialization), or cures the tissue in the screen work hole (carrier openings) of substantially crossing over fabric.This tissue can directly be crossed over screen work hole and form substantially level and smooth surface from silk material to adjacent filaments material.Tissue can be substantially forms along the tangential direction of screen work line.Inaccessible grid beam can be in the situation that the substantive substrate that participates in being provided for healing of sublevel below not having.These functions may be subject to the impact of screen work " hole dimension " or " count ".It is believed that this screen work provides the silk number (wire count) higher than existing heart defect device, thereby less hole dimension is provided, this can produce improved inaccessible performance and may eliminate increasing the needs of the polymer fabrics component of thromboembolism risk.In screen work, can use the hole dimension in about 0.10mm to 2.0mm scope.Hole dimension can be in the scope of 0.20mm to 0.75mm.
When using the silk material of two or more sizes in single screen work layer, the silk material of screen work can have diameter or average diameter.Inaccessible screen work layer can have the silk material that average diameter is less than 0.4mm.Structural Case rack-layer can have the silk material of average diameter between about 0.07mm and about 0.20mm.In addition, ratio can be by comparing the diameter of the diameter of structural screen work layer silk material or average diameter and inaccessible screen work layer silk material or average diameter to define.Structural Case rack-layer can be in the scope that comprises bound of 2: 1 to 12: 1 than such ratio of inaccessible screen work layer silk material diameter or average silk material diameter.
Figure 12 has shown the close-up view of the cross section of the blocking element that wherein screen work layer is turned up.Referring to Figure 11 A, Figure 12 shows skin 207, internal layer 209,227He hole, edge 229.Also shown and be configured between internal layer 207 and outer 209 with the shape of bearing edge 227 and maintain interior loop member or the circle 214 of the shape in hole 229.Circle 214 can be a series of circles, for example, and a series of circles that formed by the silk thread that is wound around edge 227 knotting.Figure 18 (following) is also presented at around edge and the circle at the correct position place of hub.Circle 214 can be fixed to skin 207 or internal layer 209, or is limited in screen work when screen work is turned up.
4.
blocking element shape and layering
This blocking element can have the various geometry that depends on application.For example, this blocking element can comprise one deck or more multi-layered identical screen work material or different screen work materials, have substantially cylindrical, spherical, oval shape, avette, like barrel-shaped, conical, the frustum bodily form, or other geometry.The layer of screen work can have different shapes, for example, as the wavy of flow baffles and/or conformal sealant or like the part of wave, or jagged or like the part of bellows.The thermal finalization of screen work layer can be formed to baffle plate or compartment to form radially undulation thing, diameter variation, fold, expansion etc.For example, this undulation thing can have like sinusoidal undulation.
The screen work of blocking element can have the monolayer of silk material screen work or braiding, or multilamellar screen work is provided.Two-layer can by turned up or inflection to forming from a tubular braid with it, thereby form above with reference to Figure 11 A, 11B and 12 double-layer structures of describing.Forming the two-layer net turning up can be in innermost layer, intermediate layer or the outermost layer of blocking element.Described layer can be configured to substantially coaxial form.Some of described layer or described layer can be maintained at one or more ends by common Connection Element or hub.One or more layers this layer can have the opening that is not connected element or hub maintenance.The loose end of described layer can allow different length and not coalescent at layer by catheter delivery or described in recalling while subsiding, and this is to enter contraction state because described layer can relative to each other move to adapt to the compression of blocking element.Blocking element can there is the wave of the fluctuating between two-layer cylindrical screen work layer or like the shape (referring to Figure 11 A and 11B) of bellows thus the top of undulation thing contact or almost in contact and outer cylindrical layer and the ring body that forms a plurality of closures substantially amasss.
Several settings of blocking element structure and shape and screen work layer are described in the following embodiments.Can understand, for the feature described in a concrete embodiment or the combination of feature, can be applied to another embodiment.In addition, for for purpose of brevity, previously the described total feature of embodiment was no longer described in detail, and can participate in those previous descriptions.
Figure 13 shows an embodiment of the locking device 300 similar to the embodiment of the locking device 10 shown in Fig. 4.Locking device 300 does not have two hubs of facing 28,30 (Fig. 4) of locking device 10, but locking device 300 has proximal occlusion element 316, far-end blocking element 318, and the screen work core 320 being inserted into that screen work layer is provided in path 312.Proximal occlusion element 316, far-end blocking element 318 and screen work core 320 can be by the common frame structures with one deck or more multi-layered identical or different screen work.Blocking element 300 also can comprise proximal hub 326, far-end hub 332, and the tethers 334 being connected with far-end hub 332, thereby proximal hub is pulled together with 332 can recall by the near-end of tethers 334 with far-end hub 326.
In implantation process, thereby settle far-end blocking element 318 screen work cores 320 to be placed in path 312, then settle proximal occlusion element 316.The expansion of near-end and far-end blocking element 316 and 318 remains in path 312 screen work core 320.In blocking element 316 and 318, and the screen work of configuration in screen work core 320 can be from proximal hub 326, to extend to one or more layers continuous screen work layer of far-end hub 332.Blocking element also can have the screen work in the proximal occlusion element 316 different from the screen work of far-end blocking element 318, thereby is placed the partly overlapping or interweave to provide the screen work being presented in screen work core 320 of screen work of near-end and far-end blocking element 316,318.
Figure 14 shows another embodiment that comprises blocking element 416 and be provided for being placed in the locking device 400 of the screen work core 420 in path.In this embodiment, blocking element 416 can be used separately, or is combined with the second blocking element (being now shown in Figure 14) similar in appearance to the second blocking element 18 shown in Fig. 4.
Figure 15 shows another embodiment of locking device 500, comprises proximal occlusion element 516, far-end blocking element 518, and the core 520 between proximal occlusion element 516 and far-end blocking element 518.Proximal occlusion element 516 can have taper shape with far-end blocking element 518, and the top of proximal occlusion element 516 is in proximal hub 526, and the top of far-end blocking element 518 is at far-end hub 532.Proximal occlusion element 516 can be continuous one deck of single screen work material with far-end blocking element 518, or the continuous multilamellar of identical or different screen work material.For example, proximal occlusion element 516 can have overlapping layer, the layer interweaving with far-end blocking element 518, or being fixedly connected with of one deck and another layer.
In the embodiment shown, each blocking element 516 and 518 all has the inaccessible screen work 501 of the two-layer inaccessible screen work that can be folded to form same material, and the support grid 503 in inaccessible screen work 501.Inaccessible screen work 501 can be a material net (for example, silk material fabric), and the silk material having is arranged to provide and is enough to promote quick formation and the ingrown hole dimension of cell on blocking element 516,518.Support grid 503 can be a material net (for example, silk material fabric), and the silk material having is arranged with thinking that inaccessible screen work 501 provides structural support.
In the embodiment shown, support grid 503 is connected to the interior section of proximal hub and far-end hub 526,532.For example, the end of the silk material of vital QI flowing in the body against the natural law rack-layer 503 can converge and be connected to hub 516 and 532.YIN kept externally by excess YANG in the interior rack-layer 501 can be fixed to proximal hub and far-end hub 526 and 532 by loop member 514, and this loop member 514 is fixed on the YIN kept externally by excess YANG in the interior rack-layer 501 of turning up in the outer groove 527 on the outer surface in hub 526,532.Hub 526,532 can have along the side of the side (profile) of YIN kept externally by excess YANG in the interior rack-layer 501, thereby make hub cross the outstanding of YIN kept externally by excess YANG in the interior rack-layer 501, minimizes.An embodiment of the layering of the locking device 500 shown in Figure 15 B displayed map 15A, vital QI flowing in the body against the natural law rack-layer 503 has end 503a and the 503b engaging with proximal hub and far-end hub 526 and 532.As shown, YIN kept externally by excess YANG in the interior rack-layer 501 has the two-layer layer turning up, and the first YIN kept externally by excess YANG in the interior rack-layer 501a is covered by the second YIN kept externally by excess YANG in the interior rack-layer 501b.As shown, the end 501c of YIN kept externally by excess YANG in the interior rack-layer 501 originates in core 520, through the first part 502a turning up, wherein the first YIN kept externally by excess YANG in the interior rack-layer 501a self turns back provides the second YIN kept externally by excess YANG in the interior rack-layer 501b, through the second part 502b turning up, wherein this layer is back to the first outer 501a, is then back to core 520, wherein the end 501d of YIN kept externally by excess YANG in the interior rack-layer 501 and end 501c at core 520 in engagement state overlapping or that interweave.
In an embodiment shown in Figure 16, locking device 600 has the far-end blocking element 618 of conical proximal occlusion element 616 and planar shaped, and both to be had the screen work core 620 of the overall diameter equating with the overall diameter of proximal occlusion element and far-end blocking element 616,618 connected with each other.Also shown YIN kept externally by excess YANG in the interior rack-layer 601 (the two-layer layer turning up) thereby and vital QI flowing in the body against the natural law rack-layer 603 arrange YIN kept externally by excess YANG in the interior rack-layers 601 and seal vital QI flowing in the body against the natural law rack-layer 603.In addition, vital QI flowing in the body against the natural law rack-layer 603 has silk material size and the hole dimension being enough to as being arranged to support the shape of YIN kept externally by excess YANG in the interior rack-layer 601 and the structural screen work of position or fabric, and YIN kept externally by excess YANG in the interior rack-layer 601 has and is enough to as the screen work of occlusive or silk material size and the hole dimension of fabric.Also show two proximal hub, the first proximal hub 626 and the second proximal hub 627, and far-end hub 632, the end of the silk material of vital QI flowing in the body against the natural law rack-layer 603 converges to be connected to the second proximal hub 627 and far-end hub 632.Can understand, vital QI flowing in the body against the natural law rack-layer 603 comprises undulation thing, and provides enough freedom of motion to adapt to the compression of locking device 600 when it changes between contraction state and swelling state at disconnected between two proximal hub 626,627.If interior and YIN kept externally by excess YANG in the interior rack-layer is fixed at two ends, when this device expands, this two screen works layer may interfere with each other potentially, unless the expected design of described layer is to this interference.
In Figure 16, also show as the retention element 629 of barb in order to when locking device is implanted by its maintenance to path.Retention element 629 can be can be included in YIN kept externally by excess YANG in the interior rack-layer 601 help to provide locking device 600 or approach extra fixing tooth, barb, hook, pin or the anchor of this path place to heart wall or other tissue.The length of retention element 629 can be about 1mm to 8mm, preferred about 2mm to 5mm.
Alternative form at the end of the locking device at near-end or far-end blocking element place is shown in Figure 17 A-17D.Can understand, these shapes can be applied to the single-ended or two ends of locking device, and shown layer can be in multi-layered devices.In any of described embodiment, hub can substantially be sealed or cover by screen work layer, thereby within a part for hub sees and do not expose and/or be positioned at the profile that the contour line by YIN kept externally by excess YANG in the interior rack-layer defines from the angle outside the locking device expanding.Thereby at least 50% of hub and this hub of YIN kept externally by excess YANG in the interior rack-layer can be set, by YIN kept externally by excess YANG in the interior rack-layer, be sealed or cover, or outside within the profile of screen work layer.Figure 17 A shows to have provides the locking device of conical YIN kept externally by excess YANG in the interior rack-layer 702 700, wherein thereby the screen work skin 702 of reversing is settled the not outstanding shape being defined by YIN kept externally by excess YANG in the interior rack-layer 702 of crossing of hub around recessed hub 704, and shown conical taper angle theta, it is with respect to locking device axle A, between approximately 92 degree and approximately 130 degree, more preferably between approximately 100 degree and approximately 120 degree.Figure 17 B shows the locking device 710 with the YIN kept externally by excess YANG in the interior rack-layer 712 that provides arc, and it is the radius R between approximately 0.5 and 5 times of locking device diameter that this arc curve towards interior has.Figure 17 B also shows the hub 714 with respect to the arcuate recesses of YIN kept externally by excess YANG in the interior rack-layer 712.The locking device 720 of the YIN kept externally by excess YANG in the interior rack-layer 722 with the planar shaped of providing has been provided Figure 17 C, this planar shaped is flat or dish type substantially, and the axle A perpendicular to locking device 720 is placed, and the hub 724 of profile is dwindled in demonstration, its from screen work (at this, planar shaped) profile extends (as shown with distance X, from screen work, extend) or recall (further entering in screen work), this distance X, in one embodiment, can be about 5mm, in another embodiment, can be less than about 2mm.Figure 17 D has shown to have the locking device 730 that the YIN kept externally by excess YANG in the interior of undulation shape rack-layer 732 is provided, and this undulation shape has the combination of convex surface 732a and concave surface 732b, and has shown the hub concordant with arc profile 734.
Figure 18 and 19 shows an embodiment of delivery system 800 and merosystolic locking device 802.As shown, delivery system 800 is the conduits with sheath 804, bar 806 and detachment system 808, and locking device 802 has outer screen work 810, interior screen work 812, the first hub 814 and the second hub 816.As shown in Figure 19, be the close-up view of a part of Figure 18, hub 812 has the groove 818 of the position that keeps interior and outer screen work 810 and 812, and has locking element 820, and it has tapped hole 822.Bar 806 has at its end the detachment system 808 that the screw thread mating with the female thread of hole 822 is provided.As shown in Figure 18, when instrumentation, detachment system 808 engagement locking elements 820 are so that the arrangement of locking device 802.After completing arrangement, detachment system 808 can depart from from locking element 820 by unscrewing.
In some embodiments, as shown in Figure 19, vital QI flowing in the body against the natural law rack-layer is set to subside completely completely or almost with the skin of locking device example.Subside completely, coalescent the subsiding of screen work layer in or beyond not existing, allows this device through the minimum catheter delivery of possibility shown in Figure 19.Making a kind of method that locking device subsides is skin to be set have the length substantially the same with internal layer.Or, by the mesh grid for one of screen work layer (inner or outer screen work layer), provide and compare significantly larger braid angle with the net of another screen work layer, thereby make when subsiding, one of screen work layer carries out substance adjustment for any difference of screen work layer length, and has different length with YIN kept externally by excess YANG in the interior rack-layer in making.As an example, Figure 20 shows the locking device 850 with outer screen work 852 and interior screen work 854, the first hub 856 and the second hub 858.At swelling state, compare with interior screen work 854, outer screen work 852 from hub 856 to 858 along the surface of screen work 852 there is significantly shorter total length.Can understand, when locking device 850 be shrunk to it send profile time, hub 856 and 858 separates towards each other, and the outer screen work 852 with shorter total length will seem to allow hub 856 and 858 fully separately so that allow vital QI flowing in the body against the natural law rack-layer 854 to flatten.In the embodiment of Figure 20, outer screen work 852, with than interior screen work 854 larger braid angle structure significantly, allows outer screen work 852 to extend to the length of subsiding that is enough to adapt to interior screen work 854, thereby avoids the coalescent of screen work 852 or 854.In some embodiments, the braid angle of interior screen work is between approximately 10 ° and approximately 30 °.In some embodiments, the braid angle of outer screen work is between approximately 25 ° and approximately 45 °.In some embodiments, the braid angle of outer screen work is than the braid angle of interior screen work about 30% to 70%.
In any of the embodiment of describing, can build locking device to provide eluate or one or more beneficial drugs and/or other active substance to enter sending of blood or surrounding tissue.This device can also applied various polymer strengthening the property, fixing and/or biocompatibility.This device can comprise that cell and/or other biomaterial are to promote sealing, to lower and leak or cure.In any of the embodiment of describing, this device can comprise that medicine or bioactivator are to strengthen the property and/or to contact the healing of the tissue of this device, comprise: antiplatelet drug includes but not limited to aspirin, glycoprotein lib/lila acceptor inhibitor (comprises abciximab, Eptifibatide, tirofiban, lamifiban, fradafiban, cromafiban, toxifiban, XV454, Lefradafiban, klerval, lotrafiban, orbofiban and xemilofiban), dipyridamole, apo-dipyridamole, persantin, prostacyclin, ticlopidine, clopidogrel, cromafiban, cilostazol and nitric oxide.This device also can comprise coating or other applicator of anticoagulant, for example, heparin, low molecular weight heparin, hirudin, Hua Faling, bivalirudin, hirudin, argatroban, Coleus forskohlii Briq. element (forskolin), ximelagatran (ximelagatran), vapiprost (vapiprost), prostacyclin and prostacyclin analogs, glucosan, synthetic antithrombase, Vasoflux, argatroban, efegatran, tick anticoagulant peptide, Ppack, HMG-CoA reductase inhibitor, and coagulation dioxane A2 acceptor inhibitor.
By aforementioned, understood, for illustrative purposes, described in this article the specific embodiment of this technology, but can carry out various modification in the situation that not deviating from the spirit and scope of the present invention.Therefore, the present invention is unrestricted except claims restriction of being enclosed.
Claims (39)
1. for obturation, pass the device of the path of heart tissue or vascular tissue, described path has relative opening, and described device comprises:
The expandable near-end being in alignment with each other and far-end blocking element are to define common axle, described near-end and far-end blocking element can expand around described axle, the swelling state that described near-end is respectively set to present with far-end blocking element the low profile contraction state being matched with in catheter in blood vessel and is set to cover one of the described relative opening of described path, described near-end and far-end blocking element respectively have around the core of described axle arrangement and from the extended outer peripheral portion of described core, the outer peripheral portion of each blocking element is set under swelling state contact around the tissue of one of described relative opening of described path, the core of each blocking element has and is arranged to make the described distal face of described proximal occlusion element to near-end and the far-end of the described near-end of described far-end blocking element,
Be placed in the proximal hub of each proximal end of described near-end and far-end blocking element;
Be placed in the far-end hub of each far-end of described near-end and far-end blocking element; With
Extend in the tethers between the described far-end of described proximal occlusion element and the described near-end of described far-end blocking element, described tethers has adjustable length, and it is set under swelling state toward each other near-end and far-end blocking element described in tractive,
Wherein said near-end and far-end blocking element respectively have the YIN kept externally by excess YANG in the interior rack-layer of sealing vital QI flowing in the body against the natural law rack-layer, in described, respectively there is multi-filament material with YIN kept externally by excess YANG in the interior rack-layer, the hole of screen work layer separately described in described multi-filament material is arranged to define, it is further inaccessible to promote by biological process that the hole of described YIN kept externally by excess YANG in the interior rack-layer has enough little hole dimension under swelling state.
2. for obturation, pass the device of the path of tissue, described path has at least one opening, and described device comprises:
The multi-filament material of expandable screen work of the axle of described device is defined in formation, inflatable around screen work described in described axle, described expandable screen work is configured to present swelling state and low-profile contraction state, described expandable screen work be also set to have at described swelling state, around described axle, settle and be set up the described tissue of contact with the outer peripheral portion of the described path of obturation
Wherein said multi-filament material is arranged to be defined in the hole that swelling state has enough little hole dimension and with the biological process by described expandable screen work, promotes further inaccessible.
3. device as claimed in claim 2, wherein said expandable screen work comprises the YIN kept externally by excess YANG in the interior rack-layer overlapping with vital QI flowing in the body against the natural law rack-layer.
4. device as claimed in claim 3, wherein said YIN kept externally by excess YANG in the interior rack-layer is defined as the hole of the first hole dimension, described vital QI flowing in the body against the natural law rack-layer is defined as the hole of the second hole dimension, described the first hole dimension is enough little further inaccessible to promote by the biological process on described expandable screen work under swelling state, and described the second hole dimension is greater than described the first hole dimension.
5. device as claimed in claim 2, described expandable screen work is the first expandable screen work, described device also comprises the second expandable screen work being placed on described axle, described the second expandable screen work be set up have at swelling state, around described axle, settle and be set up the described tissue of contact with the outer peripheral portion of the described path of obturation, described the first expandable screen work is set up the tissue that is positioned at least one opening of described path in order to contact under swelling state, and described the second expandable screen work is set up the tissue that is positioned at another opening of described path in order to contact under swelling state.
6. device as claimed in claim 2, one of also comprises in the multi-filament with described expandable screen work at least the hub of engagement.
7. device as claimed in claim 6, also comprises the tethers extending along described axle from described hub.
8. device as claimed in claim 6, wherein said expandable screen work defines the profile of the device crossing with described axle, with the distance of about 5mm the infall from described profile and described axle, described hub is placed in described axle.
9. device as claimed in claim 6, wherein said expandable screen work defines the profile of the device crossing with described axle, to be less than the distance of about 2mm the infall from described profile and described axle, described hub is placed in described axle.
10. device as claimed in claim 2, wherein said expandable screen work is set up in order to define butt-taper shape under swelling state, described butt-taper shape has narrow end and relative wide end, and described butt-taper shape is set up in order to settle described wide end towards described tissue.
11. devices as claimed in claim 2, wherein said expandable screen work is set up in order to define under swelling state arc, the described arc curvature being set up towards described tissue flexure that provides, described curvature defines the radius centered by described axle.
12. devices as claimed in claim 2, wherein said expandable screen work is set up to define the planar shaped in swelling state, described planar shaped has the core being placed on axle, and described planar shaped vertically extends to described axle from described core in radial direction.
13. devices as claimed in claim 2, wherein said expandable screen work is set up to define the undulation shape in swelling state.
14. devices as claimed in claim 3, wherein said YIN kept externally by excess YANG in the interior rack-layer is to have the inaccessible screen work layer that average diameter is less than the silk material of 0.4mm.
15. devices as described in any one in claim 3 and 14, wherein said vital QI flowing in the body against the natural law rack-layer is the structural screen work layer with the silk material of average diameter between about 0.07mm and about 0.20mm.
16. devices as described in any one in claim 3,14 and 15, wherein said YIN kept externally by excess YANG in the interior rack-layer is to be furnished with the inaccessible screen work layer of the silk material with the first average diameter, and described vital QI flowing in the body against the natural law rack-layer be furnished with have the second average diameter silk material structural screen work layer, described the second average diameter with the ratio of described the first average diameter in 2: 1 to 12: 1 scopes.
17. for obturation the device through the path of heart tissue or vascular tissue, described path has relative opening, described device comprises:
Formation is set to the multi-filament material of the expandable screen work of variation from low profile contraction state to swelling state, described expandable screen work defines the axle of described device, described screen work can expand around described axle, described expandable screen work has the relative cladding element being placed on described axle under swelling state, and be engaged with each other by blocking element, described blocking element is set up in order to inaccessible described path under swelling state, thereby described cladding element is configured to radially be greater than the relative opening that described blocking element covers described path under described swelling state,
Wherein said expandable screen work has the YIN kept externally by excess YANG in the interior rack-layer of sealing vital QI flowing in the body against the natural law rack-layer.
18. devices as claimed in claim 17, wherein under swelling state, the multi-filament material of described YIN kept externally by excess YANG in the interior rack-layer defines the hole of described YIN kept externally by excess YANG in the interior rack-layer, and the multi-filament material of described vital QI flowing in the body against the natural law rack-layer defines the hole of described vital QI flowing in the body against the natural law rack-layer, under swelling state, the hole dimension of described vital QI flowing in the body against the natural law rack-layer is different from the hole dimension of described YIN kept externally by excess YANG in the interior rack-layer.
19. devices as claimed in claim 17, described device also comprises the hub being placed on described axle, the interior and YIN kept externally by excess YANG in the interior rack-layer being engaged with each other by described hub.
20. devices as claimed in claim 19, wherein said hub engages described vital QI flowing in the body against the natural law rack-layer regularly.
21. devices as claimed in claim 19, wherein said expandable screen work defines the profile of the device crossing with described axle, with the distance of about 5mm the infall from described profile and described axle, described hub is placed in described axle.
22. devices as claimed in claim 19, wherein said expandable screen work defines the profile of the device crossing with described axle, to be less than the distance of about 2mm the infall from described profile and described axle, described hub is placed in described axle.
23. devices as claimed in claim 17, wherein under swelling state described cladding element one of at least have conical, butt-taper, arc, the planar shaped of the direction of described axle with sinuous shape at least one.
24. devices as claimed in claim 17, wherein said YIN kept externally by excess YANG in the interior rack-layer is to have the inaccessible screen work layer that average diameter is less than the silk material of 0.4mm.
25. devices as claimed in claim 24, wherein said vital QI flowing in the body against the natural law rack-layer is the structural screen work layer with the silk material of average diameter between about 0.07mm and about 0.20mm.
26. devices as described in any one in claim 24 and 25, wherein said YIN kept externally by excess YANG in the interior rack-layer is to be furnished with the inaccessible screen work layer of the silk material with the first average diameter, and described vital QI flowing in the body against the natural law rack-layer be furnished with have the second average diameter silk material structural screen work layer, described the second average diameter with the ratio of described the first average diameter in 2: 1 to 12: 1 scopes.
27. for obturation the device of path through tissue, described path has at least one opening, described device comprises:
Many one metal wires material of expandable screen work of the axle of described device is defined in formation, described screen work is inflatable around described axle, described expandable screen work is set up and presents swelling state and low-profile contraction state, described expandable screen work be also set up have at swelling state, around described axle, settle and be set up the described tissue of contact with the outer peripheral portion of the described path of obturation; With
With the metal hubs one of at least engaging in the multi-filament material of described expandable screen work,
Wherein said multi-filament material is arranged to be defined in the hole under swelling state with enough little hole dimension and with the biological process by described expandable screen work, promotes further inaccessible.
28. devices as claimed in claim 27, wherein said expandable screen work defines the profile of the device crossing with described axle, with the distance of about 5mm the infall from described profile and described axle, described hub is placed in described axle.
29. devices as claimed in claim 27, wherein said expandable screen work defines the profile of the device crossing with described axle, to be less than the distance of about 2mm the infall from described profile and described axle, described hub is placed in described axle.
30. devices as claimed in claim 27, wherein said device does not contain any polymers compositions.
31. devices as claimed in claim 27, wherein said expandable screen work comprises the metal YIN kept externally by excess YANG in the interior rack-layer overlapping with metal vital QI flowing in the body against the natural law rack-layer.
32. devices as claimed in claim 31, wherein said device does not contain any polymers compositions.
33. devices as claimed in claim 32, wherein said YIN kept externally by excess YANG in the interior rack-layer is to have the inaccessible screen work layer that average diameter is less than the silk material of 0.4mm.
34. devices as described in any one in claim 32 and 33, wherein said vital QI flowing in the body against the natural law rack-layer is the structural screen work layer with the silk material of average diameter between about 0.07mm and about 0.20mm.
35. devices as described in any one in claim 31-34, wherein said YIN kept externally by excess YANG in the interior rack-layer is to be furnished with the inaccessible screen work layer of the silk material with the first average diameter, and described vital QI flowing in the body against the natural law rack-layer be furnished with have the second average diameter silk material structural screen work layer, described the second average diameter with the ratio of described the first average diameter in the scope of 2: 1 to 12: 1.
The method of the 36. inaccessible paths through heart tissue or vascular tissue, described path has relative opening, and described method comprises:
The first expandable blocking element is expanded on one of described relative opening of described path;
The second expandable blocking element is expanded on another of the described relative opening of described path; With
Toward each other described in tractive the first and second blocking elements with the described path of obturation.
37. methods as claimed in claim 36, also comprise:
The described first or second expandable blocking element is expanded with inaccessible this path in described path.
The method of the 38. inaccessible paths through tissue, described path has at least one opening, and described method comprises:
The first expandable blocking element is expanded with the described path of obturation; With
The second expandable blocking element is expanded in described the first expandable blocking element.
39. methods as claimed in claim 38, also comprise:
Make described first or the hole of the second expandable blocking element hole dimension that expands to provide enough little further inaccessible to promote by biological process.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
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| US201161525680P | 2011-08-19 | 2011-08-19 | |
| US61/525,680 | 2011-08-19 | ||
| US201261636392P | 2012-04-20 | 2012-04-20 | |
| US61/636,392 | 2012-04-20 | ||
| PCT/US2012/051502 WO2013028579A1 (en) | 2011-08-19 | 2012-08-17 | Expandable occlusion device and methods |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN104039245A true CN104039245A (en) | 2014-09-10 |
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|---|---|---|---|
| CN201280048878.1A Pending CN104039245A (en) | 2011-08-19 | 2012-08-17 | Expandable occlusion device and methods |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US20140343602A1 (en) |
| EP (1) | EP2744423A4 (en) |
| JP (1) | JP6240604B2 (en) |
| CN (1) | CN104039245A (en) |
| BR (1) | BR112014003895A2 (en) |
| WO (1) | WO2013028579A1 (en) |
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Also Published As
| Publication number | Publication date |
|---|---|
| US20140343602A1 (en) | 2014-11-20 |
| BR112014003895A2 (en) | 2017-03-21 |
| JP2014529441A (en) | 2014-11-13 |
| EP2744423A1 (en) | 2014-06-25 |
| JP6240604B2 (en) | 2017-11-29 |
| EP2744423A4 (en) | 2015-06-24 |
| WO2013028579A1 (en) | 2013-02-28 |
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